STARTVerso1: A randomized trial of faldaprevir plus pegylated interferon/ribavirin for chronic HCV genotype-1 infection.

Background & Aims: The efficacy and tolerability of faldaprevir, a potent hepatitis C virus (HCV) NS3/4A protease inhibitor, plus peginterferon (PegIFN) and ribavirin (RBV) was assessed in a double-blind, placebo-controlled phase 3 study of treatment-naïve patients with HCV genotype-1 infection.

Methods: Patients were randomly assigned (1:2:2) to PegIFN/RBV plus: placebo (arm 1, n = 132) for 24 weeks; faldaprevir (120 mg, once daily) for 12 or 24 weeks (arm 2, n = 259); or faldaprevir (240 mg, once daily) for 12 weeks (arm 3, n = 261). In arms 2 and 3, patients with early treatment success (HCV-RNA <25 IU/ml at week 4 and undetectable at week 8) stopped all treatment at week 24.

Treatment of naïve patients with chronic hepatitis C genotypes 2 and 3 with pegylated interferon alpha and ribavirin in a real world setting: relevance for the new era of DAA.

Evidence based clinical guidelines are implemented to treat patients efficiently that include efficacy, tolerability but also health economic considerations. This is of particular relevance to the new direct acting antiviral agents that have revolutionized treatment of chronic hepatitis C. For hepatitis C genotypes 2/3 interferon free treatment is already available with sofosbuvir plus ribavirin.

Age-related differences in response to peginterferon alfa-2a/ribavirin in patients with chronic hepatitis C infection.

Aim: To evaluate the safety and efficacy of pegylated interferon alfa-2a and ribavirin therapy in elderly patients with chronic hepatitis C infection.

Methods: Patients characteristics, treatment results and safety profiles of 4859 patients with hepatitis c virus (HCV) infection receiving treatment with pegylated interferon alfa-2a and ribavirin were retrieved from a large ongoing German multicentre non-interventional study. Recommended treatment duration was 24 wk for GT 2 and GT 3 infection and 48 wk for GT 1 and GT 4 infection.

Chronic hepatitis C: treat or wait? Medical decision making in clinical practice.

Aim: To analyzes the decision whether patients with chronic hepatitis C virus (HCV) infection are treated or not.

Methods: This prospective cohort study included 7658 untreated patients and 6341 patients receiving pegylated interferon α 2a/ribavirin, involving 434 physicians/institutions throughout Germany (377 in private practice and 57 in hospital settings). A structured questionnaire had to be answered prior to the treatment decision, which included demographic data, information about the personal life situation of the patients, anamnesis and symptomatology of hepatitis C, virological data, laboratory data and data on concomitant diseases.

[Epidemiology and clinical characteristics of patients with chronic hepatitis B (CHB) in Germany - results of a nationwide cross-sectional study].

Background And Aims: Knowledge about the epidemiology, demography and social status of patients with replicative chronic hepatitis B (CHB) in Germany is still scarce. This cross-sectional study evaluated in patients with chronic hepatitis B infection, with a serum HBV-DNA concentration of at least 10,000 copies/mL (> 2000 IU/mL) at documentation visit, the epidemiology, socio-demographics, time of diagnosis, history of disease, prior therapies as well the therapeutic decision.

Methods: 74 German centres with predominately hepatologic focus, recorded in an online-survey the pseudonymised data of patients with chronic HBV-infection with a serum HBV-DNA-concentration of at least 10,000 copies/mL (n = 35).